The heads of the Ministry of Justice, the State Administration of Market Supervision, and the Food and Drug Administration answer questions from reporters on the Regulations on the Supervision and Administration of Medical Devices

Medical Network News, March 23, February 9, 2021, Premier Li Keqiang signed the State Council Order No.
739, promulgating the revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations").
The "Regulations" shall come into force on June 1, 2021.
A few days ago, the heads of the Ministry of Justice, the State Administration of Market Supervision, and the Food and Drug Administration answered questions from reporters on issues related to the "Regulations.
"

 

Question: Please briefly introduce the background of the revision of the Regulations.

 

Answer: Medical equipment is directly related to the lives and health of the people.
The Party Central Committee and the State Council attach great importance to the quality, safety and innovative development of medical devices.
In 2000, the State Council formulated the "Regulations on the Supervision and Administration of Medical Devices," which were comprehensively revised and partially revised in 2014 and 2017.
The "Regulations" have played an important role in ensuring the quality and safety of medical devices and promoting the healthy development of the industry.
In recent years, China’s medical device industry has developed rapidly.
The Party Central Committee and the State Council have made a series of major decisions and deployments on the reform of the drug and medical device review and approval system.
In October 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Regarding Deepening Review and Approval" Opinions on System Reform Encouraging Innovation of Drugs and Medical Devices", which provides specific opinions on deepening the reform of the medical device review and approval system.
The original "Regulations" have been difficult to adapt to the needs of the new situation, and it is necessary to amend it to further promote industry innovation from the institutional level to better meet the people's expectations for high-quality medical devices.

 

　　Question: Please briefly introduce the revision process of the Regulations.

 

　　Answer: In May 2018, the State Administration for Market Regulation submitted the "Amendment to the Regulations on the Supervision and Administration of Medical Devices (Draft for Review)" to the State Council.
After receiving the documents, the Ministry of Justice successively solicited the opinions of relevant departments, local governments, industry associations, and enterprises in writing twice , and publicly solicited opinions from the public; held several enterprise seminars and expert demonstration meetings, and went to Sichuan, Hubei, Shanghai, Jiangsu, etc.
Research on the ground.
On this basis, the Ministry of Justice, together with the State Administration for Market Regulation and the Food and Drug Administration, repeatedly studied and revised the draft submitted for review, and formed the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft).
" On December 21, 2020, the executive meeting of the State Council reviewed and approved the revised draft.
On February 9, 2021, the State Council formally promulgated the "Regulations.
"

 

　　Question: What is the general idea of ​​the revision of the "Regulations"?

 

　　Answer: The revision of the "Regulations" mainly grasps the following four points in the overall thinking: First, implement the reform requirements of the drug and medical device review and approval system, and consolidate the main responsibility of the enterprise.
The second is to consolidate the results of the reform of "delegation, control and service", optimize the approval and filing procedures, give priority to the approval of innovative medical devices, release the vitality of market innovation, and reduce the burden on enterprises.
The third is to strengthen the supervision of the whole life cycle and the whole process of medical devices, and improve the supervision efficiency.
The fourth is to increase penalties for violations and increase the cost of violations.

 

　　Question: In 2017, the Central Office and the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices", proposing to promote the full implementation of the marketing authorization holder system.
What are the provisions of the "Regulations" for medical device marketing license holders?

 

　　Answer: Medical devices are subject to classified management.
The second and third categories need to obtain marketing authorization, and the first category is subject to filing.
The "Regulations" uses the concept of "registrant and filing person", which corresponds to the concept of marketing authorization holders.
In order to implement the marketing authorization holder system, the "Regulations" made the following provisions:

 

　　The first is to clarify the definition of medical device registrant and recorder.
The enterprise or research institution that has obtained the medical device registration certificate or handled the filing shall be the registrant and filing person, and shall be responsible for the safety and effectiveness of the entire process of medical device development, production, operation, and use according to law.
The second is to clarify the obligations of the registrant and the filing person.
Refine its full-process management obligations, including establishing and effectively operating a quality management system, conducting post-marketing research and risk management, monitoring and re-evaluation of adverse events, and establishing and implementing product traceability and recall systems.
The third is to clarify the rights and obligations of other market entities such as registrants, record holders, entrusted production enterprises, e-commerce platform operators, and users.

 

　　Question: What are the provisions of the Regulations in optimizing the business environment and promoting industrial innovation?

 

　　Answer: In order to implement the reform requirements of "decentralization, management and service", further reduce the burden on enterprises, and promote high-quality industrial development, the "Regulations" mainly stipulate the following systems:

 

　　The first is to bring medical device innovation into the development focus, improve the innovation system, and provide support in scientific and technological projects, financing, credit, pharmnet.
com.
cn/news/yyzb/" target="_blank">bidding and procurement, medical insurance, etc.
, to improve independent innovation capabilities.
The second is to strengthen the information construction of medical device supervision and management, improve the level of online government services, and provide convenience for the administrative licensing and filing of medical devices.
The third is to optimize the approval procedures, reduce approval materials, and allow enterprises to submit self-inspection reports.
The fourth is to optimize the filing procedures and implement informative filing and parallel filing.
Fifth, medical devices that are used to treat rare diseases, severely life-threatening diseases without effective treatment, and respond to public health incidents and other urgently needed medical devices can be approved with conditions to speed up the market.
Sixth, implied permission for renewal of registration and clinical trials.
Seventh, the review period for production and operation licenses was shortened from 30 working days to 20 working days.
The eighth is to clarify the exemption from clinical evaluation and improve the efficiency of enterprise registration applications.
Ninth is to encourage medical institutions to carry out clinical trials, and include clinical trial conditions and capability evaluations into the level review of medical institutions.
Tenth is to allow extended clinical trials.
Medical devices that meet the requirements and are undergoing clinical trials can be used free of charge for other patients with the same condition, and their safety data can be used for medical device registration applications.

 

　　Question: In response to public health emergencies, what special institutional arrangements have been made in the Regulations?

 

　　Answer: In order to meet the needs of responding to major public health emergencies and expedite the use of urgently needed medical devices, the "Regulations" stipulate the following systems:

 

　　One is the priority review and approval system.
Prioritize review and approval of innovative medical devices.
The second is the conditional approval system.
For urgently needed medical devices such as the treatment of rare diseases, severely life-threatening diseases with no effective treatment, and response to public health events, conditional approvals can be attached to speed up the product launch.
The third is the emergency use system.
With reference to the Vaccine Management Law, it is stipulated that in the event of a particularly major public health emergency or other emergency that seriously threatens public health , medical devices can be used urgently within a certain range and time limit.
Fourth, the special approval import system is urgently needed in clinical practice.
It is stipulated that medical institutions that urgently need to import a small amount of Class II and Class III medical devices due to clinical need may be imported with the approval of the State Council's drug regulatory department or the people's governments of provinces, autonomous regions, and municipalities authorized by the State Council.
Fifth, the medical equipment system developed by medical and health institutions.
It is stipulated that medical and health institutions can develop medical devices in response to public health emergencies.
The management measures shall be formulated by the drug regulatory department of the State Council in conjunction with the health authority of the State Council.

 

　　Question: What improvements have been made to legal responsibilities in the "Regulations"?

 

　　Answer: In order to implement the "four most stringent" requirements, increase the cost of violations, protect the health of the people, and create a level playing field for law-abiding enterprises, the legal liability clauses of the original "Regulations" have been revised in three aspects: one is to substantially increase The magnitude of the fine.
Especially for violations involving quality and safety, a fine of up to 30 times the value of the goods can be imposed.
The second is to increase the penalties for prohibiting entry into the industry and the market.
In order to purify the market environment, serious offenders will be expelled from the market, and the offenders will be subject to such penalties as revocation of licenses, prohibition of related activities for a certain period of time, and failure to accept related license applications, depending on the circumstances of the violation.
The third is to increase the "punishment to the person" regulations.
For the legal representative, main responsible person, directly responsible person in charge, and other responsible personnel of a unit that has seriously violated the law, the income earned from the unit during the period of the illegal act shall be confiscated, and a fine of up to 3 times may be imposed.
related events.

　　Medical Network News, March 23, February 9, 2021, Premier Li Keqiang signed the State Council Order No.
739, promulgating the revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations").
The "Regulations" shall come into force on June 1, 2021.
A few days ago, the heads of the Ministry of Justice, the State Administration of Market Supervision, and the Food and Drug Administration answered questions from reporters on issues related to the "Regulations.
"

 

　　Question: Please briefly introduce the background of the revision of the Regulations.

 

　　Answer: Medical equipment is directly related to the lives and health of the people.
The Party Central Committee and the State Council attach great importance to the quality, safety and innovative development of medical devices.
In 2000, the State Council formulated the "Regulations on the Supervision and Administration of Medical Devices," which were comprehensively revised and partially revised in 2014 and 2017.
The "Regulations" have played an important role in ensuring the quality and safety of medical devices and promoting the healthy development of the industry.
In recent years, China’s medical device industry has developed rapidly.
The Party Central Committee and the State Council have made a series of major decisions and deployments on the reform of the drug and medical device review and approval system.
In October 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Regarding Deepening Review and Approval" Opinions on System Reform Encouraging Innovation of Drugs and Medical Devices", which provides specific opinions on deepening the reform of the medical device review and approval system.
The original "Regulations" have been difficult to adapt to the needs of the new situation, and it is necessary to amend it to further promote industry innovation from the institutional level to better meet the people's expectations for high-quality medical devices.

 

　　Question: Please briefly introduce the revision process of the Regulations.

 

　　Answer: In May 2018, the State Administration for Market Regulation submitted the "Amendment to the Regulations on the Supervision and Administration of Medical Devices (Draft for Review)" to the State Council.
After receiving the documents, the Ministry of Justice successively solicited the opinions of relevant departments, local governments, industry associations, and enterprises in writing twice , and publicly solicited opinions from the public; held several enterprise seminars and expert demonstration meetings, and went to Sichuan, Hubei, Shanghai, Jiangsu, etc.
Research on the ground.
On this basis, the Ministry of Justice, together with the State Administration for Market Regulation and the Food and Drug Administration, repeatedly studied and revised the draft submitted for review, and formed the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft).
" On December 21, 2020, the executive meeting of the State Council reviewed and approved the revised draft.
On February 9, 2021, the State Council formally promulgated the "Regulations.
"

 

　　Question: What is the general idea of ​​the revision of the "Regulations"?

 

　　Answer: The revision of the "Regulations" mainly grasps the following four points in the overall thinking: First, implement the reform requirements of the drug and medical device review and approval system, and consolidate the main responsibility of the enterprise.
The second is to consolidate the results of the reform of "delegation, control and service", optimize the approval and filing procedures, give priority to the approval of innovative medical devices, release the vitality of market innovation, and reduce the burden on enterprises.
The third is to strengthen the supervision of the whole life cycle and the whole process of medical devices, and improve the supervision efficiency.
The fourth is to increase penalties for violations and increase the cost of violations.

 

　　Question: In 2017, the Central Office and the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices", proposing to promote the full implementation of the marketing authorization holder system.
What are the provisions of the "Regulations" for medical device marketing license holders?

 

　　Answer: Medical devices are subject to classified management.
The second and third categories need to obtain marketing authorization, and the first category is subject to filing.
The "Regulations" uses the concept of "registrant and filing person", which corresponds to the concept of marketing authorization holders.
In order to implement the marketing authorization holder system, the "Regulations" made the following provisions:

 

　　The first is to clarify the definition of medical device registrant and recorder.
The enterprise or research institution that has obtained the medical device registration certificate or handled the filing shall be the registrant and filing person, and shall be responsible for the safety and effectiveness of the entire process of medical device development, production, operation, and use according to law.
The second is to clarify the obligations of the registrant and the filing person.
Refine its full-process management obligations, including establishing and effectively operating a quality management system, conducting post-marketing research and risk management, monitoring and re-evaluation of adverse events, and establishing and implementing product traceability and recall systems.
The third is to clarify the rights and obligations of other market entities such as registrants, record holders, entrusted production enterprises, e-commerce platform operators, and users.

 

　　Question: What are the provisions of the Regulations in optimizing the business environment and promoting industrial innovation?

 

　　Answer: In order to implement the reform requirements of "decentralization, management and service", further reduce the burden on enterprises, and promote high-quality industrial development, the "Regulations" mainly stipulate the following systems:

 

　　The first is to bring medical device innovation into the development focus, improve the innovation system, and provide support in scientific and technological projects, financing, credit, pharmnet.
com.
cn/news/yyzb/" target="_blank">bidding and procurement, medical insurance, etc.
, to improve independent innovation capabilities.
The second is to strengthen the information construction of medical device supervision and management, improve the level of online government services, and provide convenience for the administrative licensing and filing of medical devices.
The third is to optimize the approval procedures, reduce approval materials, and allow enterprises to submit self-inspection reports.
The fourth is to optimize the filing procedures and implement informative filing and parallel filing.
Fifth, medical devices that are used to treat rare diseases, severely life-threatening diseases without effective treatment, and respond to public health incidents and other urgently needed medical devices can be approved with conditions to speed up the market.
Sixth, implied permission for renewal of registration and clinical trials.
Seventh, the review period for production and operation licenses was shortened from 30 working days to 20 working days.
The eighth is to clarify the exemption from clinical evaluation and improve the efficiency of enterprise registration applications.
Ninth is to encourage medical institutions to carry out clinical trials, and include clinical trial conditions and capability evaluations into the level review of medical institutions.
Tenth is to allow extended clinical trials.
Medical devices that meet the requirements and are undergoing clinical trials can be used free of charge for other patients with the same condition, and their safety data can be used for medical device registration applications.

 

　　Question: In response to public health emergencies, what special institutional arrangements have been made in the Regulations?

 

　　Answer: In order to meet the needs of responding to major public health emergencies and expedite the use of urgently needed medical devices, the "Regulations" stipulate the following systems:

 

　　One is the priority review and approval system.
Prioritize review and approval of innovative medical devices.
The second is the conditional approval system.
For urgently needed medical devices such as the treatment of rare diseases, severely life-threatening diseases with no effective treatment, and response to public health events, conditional approvals can be attached to speed up the product launch.
The third is the emergency use system.
With reference to the Vaccine Management Law, it is stipulated that in the event of a particularly major public health emergency or other emergency that seriously threatens public health , medical devices can be used urgently within a certain range and time limit.
Fourth, the special approval import system is urgently needed in clinical practice.
It is stipulated that medical institutions that urgently need to import a small amount of Class II and Class III medical devices due to clinical need may be imported with the approval of the State Council's drug regulatory department or the people's governments of provinces, autonomous regions, and municipalities authorized by the State Council.
Fifth, the medical equipment system developed by medical and health institutions.
It is stipulated that medical and health institutions can develop medical devices in response to public health emergencies.
The management measures shall be formulated by the drug regulatory department of the State Council in conjunction with the health authority of the State Council.

 

　　Question: What improvements have been made to legal responsibilities in the "Regulations"?

 

　　Answer: In order to implement the "four most stringent" requirements, increase the cost of violations, protect the health of the people, and create a level playing field for law-abiding enterprises, the legal liability clauses of the original "Regulations" have been revised in three aspects: one is to substantially increase The magnitude of the fine.
Especially for violations involving quality and safety, a fine of up to 30 times the value of the goods can be imposed.
The second is to increase the penalties for prohibiting entry into the industry and the market.
In order to purify the market environment, serious offenders will be expelled from the market, and the offenders will be subject to such penalties as revocation of licenses, prohibition of related activities for a certain period of time, and failure to accept related license applications, depending on the circumstances of the violation.
The third is to increase the "punishment to the person" regulations.
For the legal representative, main responsible person, directly responsible person in charge, and other responsible personnel of a unit that has seriously violated the law, the income earned from the unit during the period of the illegal act shall be confiscated, and a fine of up to 3 times may be imposed.
related events.